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Natco Pharma Hiring for Sr Executive / Assistant Manager – DQA (API R&D)

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Natco Pharma Hiring: Sr Executive / Assistant Manager – DQA (API R&D)

About Company:
We are seeking a highly skilled and experienced Senior Executive / Assistant Manager for our DQA (API R&D) department. The ideal candidate will have a strong background in API R&D with a focus on quality assurance and process development. This role is based at our Research Center in Hyderabad, with additional responsibilities at our Ahmedabad location.

Position Name:
Sr Executive / Assistant Manager – DQA (API R&D)

Organization:
Natco Pharma

Qualifications:
M.Sc (Chemistry)

Experience:
7 – 10 years

Salary:
₹2.00 – ₹5.4 lac (Approx)

Location:
Ahmedabad (Moraiya)

Key Responsibilities:

ResponsibilityDescription
Review of CRD documentsEnsure accuracy and adequacy.
Review of Process Development Reports and Process Technology Transfer DocumentsEvaluate and approve.
Review Vendor Compliance DataAssess raw material vendors.
Evaluate Vendor Performance Reports/CommunicationsOversee the Vendor Qualification Process.
Review Extended Investigation Protocols & ReportsEnsure thorough investigation.
Prepare and review DQA SOPs/GLSDevelop and maintain standards.
Review SOPs & GLs from Cross-functional DepartmentsEnsure compliance.
Conduct Product Review MeetingsHandle specification settings, technology transfer, third-party issues, and process validation.
Oversee Quality Management System Activities in DQAManage system activities.
Establish and maintain formalized and scheduled training programs for all employees in DQATrain employees.
Perform internal audits of cross-functional departments to ensure GLP complianceConduct audits.
Maintain quality agreements with vendors & service providersEnsure compliance with agreements.
Ensure availability and updating of Site Master Layouts and Drawings in coordination with maintenanceCoordinate updates.
Review Instrument/Equipment Qualification and Calibration ReportsEnsure proper qualification and calibration.
Issue Books and FormatsManage documentation.
Handle External Samples and DocumentsOversee sample and document handling.
Evaluate business outputs and operational processesEnsure adherence to quality standards and regulations.
Maintain a strong working relationship with the SCM team and vendorsFoster collaboration.
Coordinate with corporate quality assurance for technical visits to customer sitesManage technical visits.

Preferred Background:

  • Experience in API R&D and Development Quality Assurance.
  • Previous experience transitioning from R&D to DQA roles is highly desirable.

How to Apply:
Interested and relevant experienced candidates are encouraged to share their updated CVs at Jaganmohan.p@natcopharma.co.in.

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